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In phase 3 studies, treatment with dulaglutide 1.5 mg was associated with sustained weight reduction from baseline over the duration of the studies including the longest study (AWARD-5, 104-week final endpoint) (Table 1. Changes in Body Weight From Baseline to Primary Endpoint in AWARD Studies).1-10
The LSM change in BW from baseline to primary endpoint ranged from
-0.87 kg (AWARD-4) to -3.10 kg (AWARD-10) with dulaglutide 1.5 mg treatment, and
+0.20 kg (AWARD-1 , AWARD-4) to -2.60 kg (AWARD-5, AWARD-10) with dulaglutide 0.75 mg treatment.1-10
Table 1. Changes in Body Weight From Baseline to Primary Endpoint in AWARD Studiesab
|
Primary Endpoint |
DULA 1.5 mg |
DULA 0.75 mg |
Comparator |
PBO |
p Value |
|
AWARD-31 – Comparator – MET |
|||||
|
26 weeks |
-2.29 |
-1.36 |
-2.22 |
N/A |
p<.05
DULA 1.5 mg vs DULA 0.75 mg |
|
AWARD-52,11–
Comparator – SITA and PBO a |
|||||
|
52 weeks |
-3.03 |
-2.60 |
-1.53 |
-1.61 |
p<.001 both DULA vs SITA |
|
AWARD-63
– Comparator – LIRA |
|||||
|
26 weeks |
-2.90 |
N/A |
-3.61 |
N/A |
p=.011 DULA 1.5 mg vs LIRA |
|
AWARD-84
– Comparator – PBO |
|||||
|
24 weeks |
-0.91 |
N/A |
N/A |
-0.24 |
p=.120 DULA 1.5 mg vs PBO |
|
AWARD-15
– Comparator – EXE BID and PBOa |
|||||
|
26 weeks |
-1.30 |
+0.20 |
-1.07 |
+1.24 |
p<.001
both DULA vs EXE |
|
AWARD-106
– Comparator – PBO |
|||||
|
24 weeks |
-3.10 |
-2.60 |
N/A |
-2.10 |
p=.028
DULA 1.5 mg vs PBO |
|
AWARD-27–
Comparator – GLAd |
|||||
|
52 weeks |
-1.87 |
-1.33 |
+1.44 |
N/A |
p<.001 both DULA vs GLA |
|
AWARD-98
– Comparator – PBO |
|||||
|
28 weeks |
-1.91 |
N/A |
N/A |
+0.50 |
p<.001 DULA 1.5 mg vs PBO |
|
AWARD-49
– Comparator – GLAd |
|||||
|
26 weeks |
-0.87 |
+0.18 |
+2.33 |
N/A |
p<.001 both DULA vs GLA |
|
AWARD-710
– Comparator – GLAd |
|||||
|
26 weeks |
-2.81 |
-2.02 |
+1.11 |
N/A |
p<.0001 both DULA vs GLA |
Abbreviations: AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes; BID = twice daily; DULA = dulaglutide; EXE = exenatide; GLA = insulin glargine; GLIM = glimepiride; LIRA = liraglutide; LIS = insulin lispro; LSM = least squares mean; MET = metformin; N/A = not applicable; PBO = placebo; PIO= pioglitzaone; SGLT-2 = sodium-glucose contransporter-2; SITA = sitagliptin.
a LSM Changes in body weight from baseline to primary time point are not shown for placebo.
b Data presented as LSM kg
c canagliflozin, dapagliflozin, or empagliflozin
1. Umpierrez G, Tofé Povedano S, Pérez Manghi F, et al. Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3). Diabetes Care. 2014;37(8):2168-2176. https://doi.org/10.2337/dc13-2759
2. Nauck M, Weinstock RS, Umpierrez GE, et al. Efficacy and safety of dulaglutide versus sitagliptin after 52 weeks in type 2 diabetes in a randomized controlled trial (AWARD-5). Diabetes Care. 2014;37(8):2149-2158. http://dx.doi.org/10.2337/dc13-2761
3. Dungan KM, Povedano ST, Forst T, et al. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. Lancet. 2014;384(9951):1349-1357. http://dx.doi.org/10.1016/S0140-6736(14)60976-4
4. Dungan KM, Weitgasser R, Perez Manghi F, et al. A 24-week study to evaluate the efficacy and safety of once-weekly dulaglutide added on to glimepiride in type 2 diabetes (AWARD-8). Diabetes Obes Metab. 2016;18(5):475-482. http://dx.doi.org/10.1111/dom.12634
5. Wysham C, Blevins T, Arakaki R, et al. Efficacy and safety of dulaglutide added onto pioglitazone and metformin versus exenatide in type 2 diabetes in a randomized controlled trial (AWARD-1). Diabetes Care. 2014;37(8):2159-2167. https://doi.org/10.2337/dc13-2760
6. Ludvik B, Frías JP, Tinahones FJ, et al. Dulaglutide as add-on therapy to SGLT2 inhibitors in patients with inadequately controlled type 2 diabetes (AWARD-10): a 24-week, randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2018;6(5):370-381. https://doi.org/10.1016/S2213-8587(18)30023-8
7. Giorgino F, Benroubi M, Sun JH, et al. Efficacy and safety of once-weekly dulaglutide versus insulin glargine in patients with type 2 diabetes on metformin and glimepiride (AWARD-2). Diabetes Care. 2015;38(12):2241-2249. https://doi.org/10.2337/dc14-1625
8. Pozzilli P, Norwood P, Jódar E, et al. Placebo-controlled, randomized trial of the addition of once-weekly glucagon-like peptide-1 receptor agonist dulaglutide to titrated daily insulin glargine in patients with type 2 diabetes (AWARD-9). Diabetes Obes Metab. 2017;19(7):1024-1031. http://dx.doi.org/10.1111/dom.12937
9. Blonde L, Jendle J, Gross J, et al. Once-weekly dulaglutide versus bedtime insulin glargine, both in combination with prandial insulin lispro, in patients with type 2 diabetes (AWARD-4): a randomised, open-label, phase 3, non-inferiority study. Lancet. 2015;385(9982):2057-2066. https://doi.org/10.1016/S0140-6736(15)60936-9
10. Tuttle KR, Lakshmanan MC, Rayner B, et al. Dulaglutide versus insulin glargine in patients with type 2 diabetes and moderate-to-severe chronic kidney disease (AWARD-7): a multicentre, open-label, randomised trial. Lancet Diabetes Endocrinol. 2018;6(8):605-617. https://doi.org/10.1016/S2213-8587(18)30104-9
11. Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Glossary
AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes
BW = body weight
LSM = least squares mean
Datum fӧr senaste ӧversyn 2018 M08 27